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FDA 510(k)

LDS MONITORING ELECTRODE

K-Number: K821846 · 1982-07-30

ApplicantLife Design Systems, Inc.
Decision Date1982-07-30
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LDS MONITORING ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Life Design Systems, Inc.. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821846. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDS MONITORING ELECTRODE?

LDS MONITORING ELECTRODE is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Life Design Systems, Inc.. The 510(k) number is K821846.

When did LDS MONITORING ELECTRODE receive FDA 510(k) clearance?

LDS MONITORING ELECTRODE received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821846.

Who is the listed applicant for LDS MONITORING ELECTRODE?

The FDA 510(k) record lists Life Design Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LDS MONITORING ELECTRODE?

The FDA product code for LDS MONITORING ELECTRODE is DRX.

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Other records listing Life Design Systems, Inc. as applicant

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Related Devices (Code: DRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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